TELFORD, Pa.–(BUSINESS WIRE)–Secant Group, in partnership with its sister company SanaVita Medical, announce game changing technology to advance cardiovascular regenerative medicine with the development of a synthetic, small bore, vessel that encourages endogenous regeneration and new vessel formation. The technology is based on the company’s sophisticated textile forming capabilities that can produce a hollow lumen construct that is infused with Secant’s proprietary Regenerez® bioresorbable polymer technology. The new small bore vessel supports the regeneration of new vascular tissue structures without the need for cell seeding or biologic growth promoters.

In situ vascular regeneration, along with the elastomeric and immunomodulatory properties of the synthetic vessel, could solve the problems of vascular harvesting and the non-resorbable synthetic graft compliance mismatching seen with the current technology available for surgeons today. These regenerative grafts will offer unprecedented benefits for coronary artery bypass surgery, peripheral vascular disease, and renal disease treatments.

Secant has produced small bore grafts with lumen diameters down to 500 μm, closely matching the range of human vessels. Jeff Robertson, President of Secant Group, explains, “By combining our textile manufacturing and biomaterials capability, this small bore graft would provide similar compliance as native vasculature, enabling a seamless connection between graft and vessel. A Regenerez based graft would stimulate regenerative vessel healing and cell growth, eventually degrading to leave only the native tissue behind, creating a new vessel.”

Devices that currently dominate the cardiovascular graft replacement market have numerous limitations including compliance mismatch, low patency rates, calcification, a risk of infection and lack of tissue regeneration capability. The Secant small bore graft addresses many of these limitations. Early pre-clinical studies have confirmed that Regenerez grafts are non-thrombogenic, did not show occlusion and provide excellent suturability. Secant is continuing the development of small bore grafts in collaboration with a leading heart and vascular research university. Secant Group is currently looking for medical device partners to progress this exciting new technology through clinical trials and commercialization.

About Secant Group, LLC:

Secant Group engineers medical textiles and biomedical structures that enable repair, recovery, and regeneration of the human body. Using advanced polymers, metals and composites, Secant Group partners with OEMs to design, develop, and manufacture implantable structures for medical devices that improve quality of life for patients.

About SanaVita:

SanaVita Medical® is a fully integrated contract manufacturer for medical devices. With expertise in advanced biomaterials and textile engineering, SanaVita can solve complex technical challenges and provide unique solutions that improve patient outcomes. In partnership with Secant Group, SanaVita is exclusively positioned to bridge the gap between device design and manufacturing throughout the device development process.

Marriage is the age old punch line to bad jokes about dying early, before your time. But new studies indicate that, for some, marriage actually extends life and improves outcomes! The study, by Arshed Quyyumi, of Emory University in Atlanta reports that heart disease patients who are unmarried have a higher risk of mortality than their married cohorts in a study of over 6,000 patients undergoing cardiac catheterization for CAD

Compared with patients who were married, those who were unmarried had a higher risk of all-cause mortality. Similarly, those patients who were divorced and separated had a higher risk profile than their still-married counterparts. Even after adjustment for other risk factors like prescription medicines and socioeconomic risk factors, the differences remained significant.

Study director, Quyyumi said:

“I was somewhat surprised by the magnitude of the influence of being married has on heart patients. It indicates that the social support provided by marriage, and perhaps other benefits of companionship, are important for people with heart disease.”

The Study

In this retrospective study, marital status was derived from a questionnaire at baseline of patients presenting with an AMI The group consisted of the following:

Married 4,088

Unmarried 1,963

Never married 451

Divorced or separated 842

Widowed 670

Follow-up data was collected during a follow-up phone interview, electronic health record review, Social Security Death Index, and other state records.

More Aggressive Treatment for Unmarried Patients?

While further investigation is needed to determine if more aggressive treatment strategies could influence outcomes for unmarried patients.

“Accounting for unmarried status in the management of patients with CAD, consideration of associated psychological conditions, and potentially more aggressive follow-up and therapy need to be considered in future studies,” wrote the study authors.

The researchers also listed the study limitations which included the retrospective analysis, single-center study, and lack of follow-up regarding continued marital status.

Our strategy focuses on enabling our clients to identify, attract and retain the right people for the structure in which they will perform. Please contact us to learn more about our expertise in Executive Search for Leadership positions in Medical Device and Biotechnology. We look forward to the opportunity to help you consistently improve your performance and your business!

HOUSTON–(BUSINESS WIRE)–Saranas, a medical device company with a new technology for real-time detection and monitoring of internal bleeding during endovascular procedures, today announced the company was named as one of the Top 4 Innovators at the International Conference for Innovations in Cardiovascular Systems (ICI) in Tel Aviv, Israel.

The ICI Innovation Award is one of the most significant and prestigious awards for medical intervention startups worldwide. The competition is a central element of the ICI conference, which attracts more than 1,800 attendees, including scientists, entrepreneurs, investors, medical device and pharmaceutical executives, and medical professionals specializing in cardiovascular interventions.

“We are very pleased and humbled to be recognized by this international conference as one of the four top cardiovascular innovators,” Saranas President and CEO Zaffer Syed said. “It is further validation that our Early Bird™ Bleed Monitoring System can have an important impact on healthcare costs and reduce the risk of death in patients undergoing endovascular procedures. This recognition from ICI provides substantiation that our innovative technology is disruptive and important for patients.”

The Early Bird includes a vascular access sheath with embedded sensors that are designed to detect and monitor bleeding from a blood vessel accidentally injured during endovascular procedures, such as a transcatheter aortic valve replacement, large bore hemodynamic support device placement, or other complex cardiac interventions, where the femoral artery or vein is used to gain vascular access to the heart. The technology was invented at the Texas Heart Institute.

Saranas Chief Medical Officer Dr. Philippe Genereux observed, “Our Early Bird system is designed to protect and in some cases, save the lives of patients undergoing an endovascular procedure by letting doctors detect the onset of bleeding early and take appropriate steps to address the bleed and allow the procedure to continue.”

Each year, more than 20 million people in the U.S. undergo vascular access procedures. About 5%, or 1 million of them, will experience severe procedural bleeding complications, resulting in significant additional healthcare expenditures and placing the patients at an increased risk of death. These “blind” bleeds are typically unnoticed until meaningful symptoms are present, by which time their management is much more challenging and can compromise patient outcomes. By being able to detect the onset of bleeding early, the Saranas Early Bird Bleed Monitoring System allows physicians to appropriately address the bleed and to continue the procedure.

Med-tech company HeartFlow is using AI and machine learning to combat heart disease. It’s estimated that coronary artery disease is the root cause of nearly 9 million deaths each year. Heart disease is difficult to diagnose because the best test for it was a heart cath —which is both invasive and costly.

The AI Solution

HeartFlow is non-invasive, combining standard CT scans with involved fluid dynamics and deep learning algorithms to capture a 3D image of a patient’s heart. This model gives doctors a detailed view of blockages and blood flow. Creating these 3D models of the heart is a challenge. First an accurate subvoxel model is made. Then the system simulates the flow of blood, through the arteries to reveal any blockages or turbulence.

Because this technology enables physicians to provide precise treatment for each individual patient, it has the potential to greatly improve quality of life. It also means fewer patients will make a trip to cath lab, reducing healthcare costs by approximately 25%.

The Outlook

With a shift to value based medicine, health delivery organizations are looking for ways to decrease waste, lower costs, and improve outcomes. With HeartFlow, physicians make definitive and personalized decisions more quickly and with greater precision, leading to better outcomes for patients.

Our strategy focuses on enabling our clients to identify, attract and retain the right people for the structure in which they will perform. Please contact us to learn more about our expertise in Executive Search for Leadership positions in Medical Device and Biotechnology. We look forward to the opportunity to help you consistently improve your performance and your business!

RARITAN, N.J., Dec. 11, 2017 /PRNewswire/ — Janssen Research & Development today announced it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for two new XARELTO® (rivaroxaban) vascular indications: reducing the risk of major cardiovascular (CV) events such as CV death, heart attack or stroke in patients with chronic coronary and/or peripheral artery disease (CAD/PAD), and for reducing the risk of acute limb ischemia in patients with PAD. This application is based on data from the landmark COMPASS study, the only randomized trial to investigate a Factor Xa inhibitor for preventing major CV events in this population.

Both CAD and PAD occur when arteries become hardened or narrowed due to a buildup of cholesterol and plaque, limiting blood flow to parts of the body. While long-term aspirin use helps prevent CV events, it is only modestly effective and, despite use of preventative medicines as directed by current guidelines, an underlying thrombotic risk remains and people with CAD or PAD could still have a serious or fatal CV event.i

“Coronary artery disease (CAD) and peripheral artery disease (PAD) impact millions of Americans and can lead to heart attack, stroke, and death. At Janssen, we want to help prevent the potentially devastating and irreversible harm associated with CV events that often occur in these patients,” said James F. List, MD, PhD, Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen. “Based on the results of COMPASS, we believe the combination of the vascular dose of XARELTO® (2.5 mg twice daily) plus aspirin can provide important benefits and potentially change the way physicians treat patients with CAD and PAD, if approved.”

About COMPASS
The COMPASS study showed that the XARELTO® vascular dose of 2.5 mg twice daily plus aspirin 100 mg once daily significantly reduced the risk of major CV events defined as CV death, heart attack or stroke by 24 percent in patients with chronic CAD and/or PAD compared to aspirin alone. This finding was driven by a robust 42 percent reduction in stroke and 22 percent reduction in CV death. The risk of major bleeding was significantly higher in patients taking the XARELTO®/aspirin regimen compared to aspirin alone, with no significant increase in fatal or intracranial bleeds. COMPASS was stopped early, approximately one year ahead of schedule, due to efficacy, and its results were presented during a Hot Line session at the ESC Congress 2017 and simultaneously published in The New England Journal of Medicine. In addition, two sub-analyses from COMPASS in patients with PAD and CAD were recently published in The Lancet.

COMPASS is a Phase 3 clinical study of 27,395 patients with chronic CAD and/or PAD from 33 countries that examined the use of XARELTO®, alone or in combination with aspirin, in the long-term prevention of major adverse cardiovascular (CV) events, including heart attack, stroke or CV-related death.

About EXPLORER
The EXPLORER program is unmatched by any oral anticoagulant in the Factor Xa inhibitor class in its size, scope and ambition. A collaborative effort between Janssen and Bayer, EXPLORER seeks to generate important clinical evidence on the safety and efficacy of XARELTO® and its potential role in addressing critical unmet medical needs. Several of the studies, including COMPASS, are designed to seek additional indications or expand the label for XARELTO® to benefit more patients in need of additional therapies for their cardiovascular disease. By the time of its completion, more than 275,000 patients will have participated in the EXPLORER clinical development program, other completed and ongoing clinical trials, investigative registries and non-interventional studies.

WHAT IS XARELTO®?

XARELTO® (rivaroxaban) is a prescription medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how XARELTO® and warfarin compare in reducing the risk of stroke.

XARELTO® is also a prescription medicine used to treat deep vein thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of blood clots happening again in people who continue to be at risk for DVT or PE after receiving treatment for blood clots for at least 6 months.

XARELTO® is also a prescription medicine used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know aboutXARELTO® (rivaroxaban)?

For people taking XARELTO® for atrial fibrillation: People with atrial fibrillation (an irregular heart beat) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. XARELTO® lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO®, you may have increased risk of forming a clot in your blood.Do not stop taking XARELTO® without talking to the doctor who prescribes it for you. Stopping XARELTO® increases your risk of having a stroke.

If you have to stop taking XARELTO®, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming.

XARELTO® can cause bleeding, which can be serious, and rarely may lead to death. This is because XARELTO® is a blood thinner medicine (anticoagulant) that reduces blood clotting. While you take XARELTO® you are likely to bruise more easily, and it may take longer for bleeding to stop.You may have a higher risk of bleeding if you take XARELTO® and take other medicines that increase your risk of bleeding, including:

Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.

Call your doctor or get medical help right away if you develop any of these signs or symptoms of bleeding:

Unexpected bleeding or bleeding that lasts a long time, such as:

Nosebleeds that happen often

Unusual bleeding from gums

Menstrual bleeding that is heavier than normal, or vaginal bleeding

Bleeding that is severe or you cannot control

Red, pink, or brown urine

Bright red or black stools (looks like tar)

Cough up blood or blood clots

Vomit blood or your vomit looks like “coffee grounds”

Headaches, feeling dizzy or weak

Pain, swelling, or new drainage at wound sites

Spinal or epidural blood clots (hematoma): People who take a blood thinner medicine like XARELTO®, and have medicine injected into their spinal and epidural area, or have a spinal puncture, have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:

A thin tube called an epidural catheter is placed in your back to give you certain medicine

You take NSAIDs or a medicine to prevent blood from clotting

You have a history of difficult or repeated epidural or spinal punctures

You have a history of problems with your spine or have had surgery on your spine

If you take XARELTO® and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness (especially in your legs and feet), or loss of control of the bowels or bladder (incontinence).

XARELTO® is not for people with artificial heart valves.

Do not take XARELTO® if you:

Currently have certain types of abnormal bleeding. Talk to your doctor before taking XARELTO® if you currently have unusual bleeding.

Are allergic to rivaroxaban or any of the ingredients of XARELTO®.

Before taking XARELTO®, tell your doctor about all your medical conditions, including if you:

Have ever had bleeding problems

Have liver or kidney problems

Are pregnant or plan to become pregnant. It is not known if XARELTO® will harm your unborn baby.

Tell your doctor right away if you become pregnant during treatment with XARELTO®. Taking XARELTO® while you are pregnant may increase the risk of bleeding in you or in your unborn baby.

If you take XARELTO® during pregnancy, tell your doctor right away if you have any signs or symptoms of bleeding or blood loss. See “What is the most important information I should know about XARELTO®?” for signs and symptoms of bleeding.

Are breastfeeding or plan to breastfeed. XARELTO® may pass into your breast milk. You and your doctor should decide if you will take XARELTO® or breastfeed.

Tell all of your doctors and dentists that you are taking XARELTO®. They should talk to the doctor who prescribed XARELTO® for you before you have any surgery, medical or dental procedure.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way XARELTO® works. Certain medicines may increase your risk of bleeding. See “What is the most important information I should know about XARELTO®?”

If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.

Blood clots in the veins of your legs or lungs:

Take XARELTO®1 or 2 times a day as prescribed by your doctor.

For the 15-mg and 20-mg doses, XARELTO®should be taken with food.

For the 10-mg dose, XARELTO®may be taken with or without food.

Take your XARELTO® dose(s) at the same time each day.

If you miss a dose:

If you take the 15-mg dose of XARELTO® 2 times a day (a total of 30 mg of XARELTO® in 1 day): Take XARELTO®as soon as you remember on the same day. You may take 2 doses at the same time to make up for the missed dose. Take your next dose at your regularly scheduled time.

If you take XARELTO® 1 time a day: Take XARELTO® as soon as you remember on the same day. Take your next dose at your regularly scheduled time.

Hip or knee replacement surgery:

Take XARELTO® 1 time a day with or without food.

If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.

If you have difficulty swallowing the XARELTO® tablet whole, talk to your doctor about other ways to take XARELTO®.

Your doctor will decide how long you should take XARELTO®.

Your doctor may stop XARELTO® for a short time before any surgery, medical or dental procedure.

Your doctor will tell you when to start taking XARELTO® again after your surgery or procedure.

Do not run out of XARELTO®. Refill your prescription for XARELTO® before you run out. When leaving the hospital following a hip or knee replacement, be sure that you have XARELTO® available to avoid missing any doses.

If you take too much XARELTO®, go to the nearest hospital emergency room or call your doctor right away.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO®?

See “What is the most important information I should know about XARELTO®?”

Call your doctor for medical advice about side effects. You are also encouraged to report side effects to the FDA: visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).

Trademarks are those of their respective owners.

About the Janssen Pharmaceutical CompaniesAt the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.

We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us on Twitter at@JanssenUS.

Cautions Concerning Forward-Looking StatementsThis press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding development of, and potential approval of new indications for, XARELTO® (rivaroxaban). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including under “Item 1A. Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including under the caption “Cautionary Note Regarding Forward-Looking Statements,” and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

Company Profile

"Prime-Core, Inc is an Executive Search Firm that is passionate about helping med tech companies meet their Human Capital needs in order to foster a team dedicated to success.
We believe there is a story behind every successful hire. One that stands the tests of time and truly transforms a good company to great company."